Catalog Number

215-2023

Brand Name

Aveta Auto 5 Fr Disposable Resecting Device

Version/Model Number

215-2023

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

ae8e0c19-4c84-481d-ab35-7ee76ecf22fc

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Package DI Number

00850006759675

Quantity per Package

3

Contains DI Package

00850006759668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shelf carton